Selinexor in Combination With MTX+Ritu to Treat R/R CNSL
ConditionCentral Nervous System Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTong Chen, MD
About this trial
This is a single-arm and open-label study to explore X+MTX+Ritu (ATG-010, Methotrexate, Rituximab) regimen in Relapse refractory PCNSL patients. Approximately 30 patients will be enrolled in the study. In dose escalation phase, patients with Relapse refractory PCNSL will be treated with X+MTX+Ritu regimen and escalating doses of oral ATG-010 weekly in a 3+3 design. Then a phase 2 expansion at the recommended dose level based on phase 1b trial will be conducted to evaluate the efficacy, safety and tolerability.
Eligibility criteria
Qualifiers
Participants must be able to understand and be willing to sign a written informed consent document.
Men and woman who are 18-75 years old on the day of consenting to the study.
Histologically documented PCNSL and SCNSL secondary to histologically documented systemic diffuse large B-cell lymphoma (DLBCL).
Patients must have relapsed/refractory PCNSL or relapsed/refractory SCNSL.
Disqualifiers
Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded.
Lymphoma patients with only intraocular involvement.
Pathological diagnosis of PCNSL is T-cell lymphoma.
Patients with disease progression within 6 months of prior methotrexate-containing regimen.
Trial design
Treatments tested in this trial
- Selinexor
- Rituximab
- Methotrexate
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov